WO2011154372A1 - Capteur d'analyte pourvu d'une antenne à fente - Google Patents

Capteur d'analyte pourvu d'une antenne à fente Download PDF

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Publication number
WO2011154372A1
WO2011154372A1 PCT/EP2011/059327 EP2011059327W WO2011154372A1 WO 2011154372 A1 WO2011154372 A1 WO 2011154372A1 EP 2011059327 W EP2011059327 W EP 2011059327W WO 2011154372 A1 WO2011154372 A1 WO 2011154372A1
Authority
WO
WIPO (PCT)
Prior art keywords
metal housing
slot
sensor
medical device
housing
Prior art date
Application number
PCT/EP2011/059327
Other languages
German (de)
English (en)
Inventor
Bernd Rösicke
Original Assignee
Roche Diagnostics Gmbh
F. Hoffmann-La Roche Ag
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Roche Diagnostics Gmbh, F. Hoffmann-La Roche Ag filed Critical Roche Diagnostics Gmbh
Priority to EP11723090.4A priority Critical patent/EP2579769A1/fr
Priority to CN2011800282591A priority patent/CN102917636A/zh
Publication of WO2011154372A1 publication Critical patent/WO2011154372A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14546—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring analytes not otherwise provided for, e.g. ions, cytochromes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/1486—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using enzyme electrodes, e.g. with immobilised oxidase
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00—Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/12—Manufacturing methods specially adapted for producing sensors for in-vivo measurements

Definitions

  • the invention relates to a medical device for performing at least one medical function on a human or animal body.
  • the invention relates to a sensor device for monitoring at least one body function, in particular for detecting at least one analyte in a body fluid.
  • the invention relates to a method for producing a medical device for performing at least one medical function on a human or animal body and in particular a method for producing a sensor device for monitoring at least one body function, in particular for detecting at least one analyte in a body fluid, in particular a method for producing a medical device according to the invention.
  • Such medical devices and in particular sensor devices are generally used in medical therapeutics and diagnostics, for example in order to influence and / or monitor body functions.
  • Examples are the continuous or discontinuous monitoring of analyte concentrations in at least one body fluid such as interstitial fluid or blood.
  • Suitable analytes to be monitored are, for example, glucose, cholesterol, lactate, a metabolite in general or other types of analyte or analyte combinations.
  • glucose, cholesterol, lactate, a metabolite in general or other types of analyte or analyte combinations are examples.
  • the term “analyte” is to be construed broadly and may include one or more chemical substances.
  • the present invention is generally applicable to other medical devices and devices in the field of diagnostics, therapeutics or surgery, since in principle, for example, instead of one or more analytes, at least one arbitrary body function can be detected by the sensor device and / or because basically any physio -physical sensors, for example, for blood pressure, temperature or movement, and / or actuators for influencing at least one body state fiction, can be designed according to.
  • any physio -physical sensors for example, for blood pressure, temperature or movement, and / or actuators for influencing at least one body state fiction
  • the monitoring of certain body functions plays an essential role in the prevention and treatment of various diseases. Without limiting other possible applications, the invention will be described below with reference to blood glucose monitoring. In principle, however, the invention can be applied to other types of analytes and / or the monitoring and / or the influencing of other types of bodily functions.
  • US Pat. No. 6,409,675 B1 discloses a method and a device for monitoring a hemodynamic status of a patient. Among other things, a monitoring device is described. In addition, a use of a slot antenna is proposed.
  • US 2007/0167867 A1 discloses a system for measuring an internal physiological parameter of a medical patient.
  • an implanted sensor module is used.
  • a telemetry signal is transmitted in the form of an NIR signal.
  • the implant has a gold-plated electrode surface which has a slot structure for avoiding eddy currents.
  • a central opening is provided, which is without metallization and which allows transmission of the infrared signals.
  • No. 5,394,882 describes a wireless monitoring system having a first unit for detecting a movement of a patient and a second unit for receiving signals of the first unit.
  • a first unit for detecting a movement of a patient
  • a second unit for receiving signals of the first unit.
  • an embodiment of the first unit is described, in which a disk-shaped slot antenna is used.
  • EP 2 187 555 AI an overcoming device for an analyte is known.
  • a construction of a corresponding sensor electronics will be described.
  • US 2009/0182426 A1 discloses an implantable medical device.
  • an antenna structure is described.
  • a metallic housing is used, wherein an antenna compartment made of a dielectric material extends outwardly around the housing, with an antenna embedded therein.
  • spot measurements in which a user is specifically taken a sample of a body fluid and examined for the analyte concentration, continuous measurements with an analyte monitoring are increasingly establishing themselves.
  • continuous glucose monitoring in the interstitium also known as continuous monitoring, CM
  • CM continuous monitoring
  • NTS needle-type sensors
  • the active sensor region is brought directly to the measurement location, which is usually arranged in the interstitial tissue, and, for example, using an enzyme (for example glucose oxidase, GOD) converts glucose into electrical charge, which is in proportion to the glucose concentration and as a measured variable can be used.
  • an enzyme for example glucose oxidase, GOD
  • Examples of such transcutaneous measuring systems are described in US Pat. No. 6,360,888 Bl or in US 2008/0242962 A1.
  • the sensor and optionally directly related components such as an insertion needle
  • the sensor and optionally other replaceable components usually constitute a so-called disposable part.
  • the evaluation and control part of the system is reused in most cases. Accordingly, this evaluation and control part is usually designed as a so-called reusable part (Reusable).
  • the separation according to the prior art into at least one disposable and at least one reusable furthermore has the background that fully or partially implantable components for use on humans and / or animals are to be sterilized in accordance with the applicable standards.
  • the enzyme is embedded in the electrodes and in contact with the interstitium, ie the electrodes are open.
  • the system is permanently, either wholly or partially (in particular the sensor), in a body tissue and thus in an aqueous environment and / or is constantly exposed to a very high relative humidity (in particular the reusable).
  • This promotes the formation of parasitic leakage resistances and / or leakage currents.
  • the entire structure is therefore suitable to seal.
  • the plug connection forms a weak point of the insulation, since easily parasitic leakage resistances and leakage currents can form in the region of the plug connection.
  • the medical device in a metallic protective housing which is hermetically coupled to a carrier substrate which carries the sensitive semiconductor components.
  • shields basically have numerous disadvantages in the known systems.
  • the sensor is located in the interstitium, and the measurement processing and storage part outside the body, directly on the skin, but below the clothing.
  • the continuously or discontinuously recorded glucose measured values are buffered and, if necessary, transmitted to an external device, for example a data manager, a PDA (Personal Digital Assistant), a PC or a mobile communication device, for example by radio (radio frequency transmission, RF), and visualized there and / or further processed.
  • RF radio frequency transmission
  • the invention could in principle also be applied to other types of medical devices which comprise at least one implanted and / or implantable element, for example general physical-physical sensors, for example invasive actuators such as pacemakers, insulin pumps, drug dosing systems or the like.
  • general physical-physical sensors for example invasive actuators such as pacemakers, insulin pumps, drug dosing systems or the like.
  • invasive actuators such as pacemakers, insulin pumps, drug dosing systems or the like.
  • communication via electromagnetic waves is particularly suitable.
  • optical systems are basically suitable for communication, but have the disadvantage of a necessary line of sight to the receiver, which is not given especially in the subcutaneous area or below the clothing.
  • Necessary components of radio systems are antennas for receiving or emitting electromagnetic waves. However, these are usually realized by metallic structures in air.
  • dipole antennas and / or half-dipole antennas in various embodiments are used for the present applications.
  • Such anisotropic antennas act bidirectionally as transmitting and receiving antennas.
  • Antennas can be adapted to the specific frequency and tasks by their shape and size. If, however, as in EP 1 178 841 B1, a metallic protective housing is provided, as a rule the antenna is also completely shielded with a metallic shield. Through this metallic shield, which acts as a Faraday cage, electromagnetic waves neither enter nor leave. Accordingly, the metallic shield required to shield the ionizing radiation during sterilization adversely affects the communication characteristics of the sensor element.
  • slot antennas are known in principle, for example in aerospace technology, for example in W. Ren: Compact Dual-Band Slot Antenna for 2.4 / 5 GHz WLAN Applications, Progress In Electromagnetics Research B, Vol. 8, 319-327, 2008, an integration of slot antennas in the form of square or circular ring columns in high-fidelity circuits for WLAN communication.
  • the medical device should be able to be sterilized in a simple manner by means of customary sterilization methods, without this causing damage to sensitive electronic components of the medical device.
  • the medical device should be set up so that it can communicate wirelessly with other components.
  • a medical device for performing at least one medical function on a human or animal body.
  • a medical device is generally understood to mean a device which is set up to perform a medical function.
  • a medical function is generally to be understood as a function which has a therapeutic and / or surgical and / or diagnostic effect.
  • the device can be set up to influence and / or detect at least one body function of the human or animal body. For example, this may be a physiological and / or a physical condition of the body.
  • the device can be designed, for example, wholly or partly as a sensor device and / or comprise a sensor device.
  • the device may, for example, be wholly or partially designed as an actuator and / or comprise at least one actuator, wherein the actuator can exert at least one stimulus on the body or a part of the body and / or influence the body in another way can.
  • the actuator can be set up, for example, to exert a physical and / or chemical stimulus on the body.
  • the actuator can exert an electrical stimulus on the body, for example with one or more stimulating electrodes.
  • the device can be wholly or partly designed as a pacemaker, with at least one electrical actuator in the form of one or more stimulating electrodes.
  • the device may also exercise, for example, a chemical stimulus.
  • the device may be wholly or partially configured as a medication device and may, for example have at least one actuator in the form of a medication pump and / or in the form of an active substance dispenser.
  • the invention will be described in the following essentially with reference to medical devices which are wholly or partly designed as a sensor device or which comprise at least one sensor device.
  • This sensor device can generally be designed to monitor at least one body function and, with particular preference, to be set up for qualitative and / or quantitative detection of at least one anemia in a body fluid.
  • the monitoring of the body function can basically be based on one or more physical and / or chemical and / or biological detection methods or measuring methods.
  • this may be an electrochemical measurement and / or an optical measurement.
  • one or more analytes can be detected chemically, electrochemically or optically.
  • body function in the context of the present invention is to be understood in principle as meaning one or more detectable properties and / or measured variables of a human or animal body. In particular, it may be one or more properties which are characteristic of a state of health of the body. In particular, the body function may be at least one physiological function and / or at least one physiological characteristic of the body.
  • Examples of possible bodily functions that can be detected individually, in any combination, or in combination with other bodily functions are: a blood pressure; a pressure of at least one other body fluid and / or at least one organ of the body; a heart rate; a respiratory rate; a temperature of the body and / or part of the body; a presence or absence or concentration of one or more antibodies in at least one body fluid of the body, especially in blood; a concentration of at least one anaiyte in at least one body fluid, which concentration may be detected qualitatively (presence or absence of the anemia) and / or quantitatively.
  • the invention will in the following, without limitation to a detection of other possible body functions, substantially with reference to a qualitative and / or quantitative detection of at least one analyte in at least one body fluid.
  • the analyte may comprise at least one metabolite, for example glucose and / or lactate and / or cholesterol.
  • the body fluid may in particular be selected from the group consisting of blood, interstitial fluid, saliva and urine.
  • the sensor device can be set up in particular for the continuous qualitative and / or quantitative detection of the at least one analyte. Accordingly, the sensor device can be used in particular in the context of a continuous monitoring, ie a long-term monitoring over a period of several hours to several days or even several weeks or months.
  • other embodiments are possible in principle.
  • the medical device comprises at least one implantable functional element.
  • the sensor device may comprise at least one implantable sensor element.
  • the medical device comprises at least one drive with at least one electronic component.
  • the functional element can be completely or partially implantable.
  • an active part and / or a sensitive part of the functional element can be implanted in a body tissue of a user, whereas a lead can protrude from the body tissue.
  • other embodiments, such as fully implanted embodiments, are in principle possible.
  • a functional element is generally to be understood as an element which can perform in the medical device the at least one medical function alone or in cooperation with other elements of the medical device.
  • this may be a sensitive element that can detect the body function or, for example, generate at least one signal that indicates the function of the body.
  • this may be an electrical and / or an optical signal.
  • this may be an active element, wherein the active element is arranged, for example, to exert one or more of the above stimuli on the body or part of the body, for example one or more electrical stimuli and or one or more physiological stimuli, for example in the form of one or more medications.
  • the term implantable is to be understood in general terms as meaning that the functional element can be wholly or partly introduced into a body tissue of the human or lower body. This introduction can take place, for example, transcutaneously or subcutaneously, for example as part of a surgical procedure. Accordingly, the term implantable implies that the functional element should first be sized appropriately to be introduced into the body tissue.
  • the functional element or, for example, an implantable part of the functional element can be designed such that it has a volume of not more than 3 cm 3 , preferably of not more than 1 cm 3 .
  • the functional element should have biocompatible properties, at least on its surface.
  • the functional element should not dissolve on contact with compassionfiüsstechniken and / or body tissue and / or should not release toxic substances such as heavy metals.
  • a corresponding passivation and / or coating can also be provided to produce biocompatibility.
  • the sensor element may have at least one sensor chemistry which, in the presence of the at least one analyte, alters at least one detectable property, for example an electrochemically and / or optically detectable property.
  • the implantable sensor element is a sensor element for the electrochemical detection of the at least one analyte, for example a sensor element having at least two, preferably at least three electrodes, for example a working electrode and a reference and / or counter electrode.
  • other embodiments are possible in principle.
  • the control serves to assist the functional element in carrying out the medical function and or to stimulate the functional element to carry out the medical function.
  • the functional element exerts at least one stimulus on the body
  • an activation can be provided, for example, which specifies a point in time and / or an intensity and / or duration of the exertion of the stimulus on the body.
  • the driver may also provide energy for the exercise of this stimulus.
  • the control can record, for example, measured values and / or signals supplied by the sensor element and, if necessary, provide them for an evaluation.
  • the evaluation may include, for example, a measurement signal conditioning, in particular a so-called analog front-end (AFE), and / or a memory part.
  • the control can generally also include a power supply.
  • the at least one electronic component may in particular comprise at least one sensitive semiconductor component, for example an operational amplifier and / or another type of semiconductor component.
  • the electronic component may further include an application specific integrated circuit (ASIC).
  • ASIC application specific integrated circuit
  • the electronic component can be any electronic component which could damage the radiation during sterilization with ionizing radiation.
  • an electronic component is to be understood as meaning any component, in particular a semiconductor component, which has at least one electronic function, for example a device function, an amplifier function, a transistor function, a memory function, a logical function, a function of a precise DC voltage source and / or DC power source, can perceive a clock function, a control function or another type of electronic function. Also combined electronic components are used, so components with more than one function.
  • the functional element in particular the sensor element, can be connected to the control.
  • the term "connectable” is generally understood to mean the possibility of establishing a connection between the interconnectable elements, in particular an electrical and / or mechanical connection, for example by one or both interconnectable elements comprising one or more connecting elements, for example at least one connector or similar.
  • the term connectable also includes the possibility that the interconnectable elements, in particular the functional element (in particular the sensor element) and the control, are already reversibly or permanently connected to one another.
  • the connection can, for example, as will be explained in more detail below, take place via a fixed or permanent connection, that is, via a connection which is not detachable by the user, at least not non-destructive.
  • this connection can take place via a cable or a part of the functional element, in particular of the sensor element itself.
  • the sensor element can be designed, for example, as a flexible film sensor element, at one end of which the electrodes of the sensor element are arranged, and with its other end the control is connectable or already connected.
  • the drive has a housing with at least one metal housing. This means that the control is completely or partially surrounded by a housing which shields the control against environmental influences, in particular with respect to Humidity. Under a housing is thus generally an element to understand, which has a shielding effect at least against mechanical influences or chemical influences and at least one completely or partially closed interior, in which at least one element to be protected is added.
  • the housing in turn has at least one metal housing, that is to say a housing which is made wholly or partly from at least one metallic material.
  • the housing of the drive can be configured completely as a metal housing, or the metal housing can only form part of the entire housing.
  • a metal housing is to be understood as meaning a housing which is completely or partially made of at least one metallic material.
  • the metal housing should be completely, predominantly or at least partially made of at least one metallic material and / or should preferably comprise no or only a very few non-metallic components, or at least one metallic material in addition to one or more non-metallic components include.
  • At least one metallic material can also be introduced as a filler into at least one non-metallic material, for example a plastic material.
  • the metal housing may also comprise at least one layer structure, with at least one non-metallic layer and at least one layer of a metallic material.
  • a laminate construction can be used.
  • several properties can be improved or even optimized, for example, sealing properties against penetration of media such as moisture and shielding properties, for example against electromagnetic radiation and / or against ionizing radiation.
  • the metal housing may have a laminate structure in which one or more metal layers are combined with one or more plastic layers, for example by using a plastic layer as the outermost layer, which serves as a seal and / or also as corrosion protection and / or to increase biocompatibility serves.
  • the metal may for example comprise aluminum, copper, iron, lead or other metals or a combination (for example a mixture and / or an alloy and / or a layer structure with layers of different metals) of these and / or other metals.
  • the metal housing may have a thickness which is at least 0.5 mm, preferably at least 1 mm or even at least 2 mm.
  • the metal housing may in particular have a total thickness of between 0.5 mm and 10 mm, preferably a thickness of 1 mm to 5 mm, for example a thickness of 2 mm to 3 mm.
  • the thickness may be dependent on the choice of material, for example. If several layers are provided, for example, the individual layers may each have a di- from 0.05 mm to 8 mm, for example from 0.1 mm to 5 mm and more preferably from 0.2 mm to 3 mm.
  • a compromise can be achieved with the structure on the one hand with regard to the shielding thickness and the radiation damping on the one hand and with regard to the requirements for the lowest possible volume and / or the lowest possible weight on the other hand.
  • the drive also has at least one wireless communication device.
  • a wireless communication device is to be understood as a device which enables the control to communicate unidirectionally or bidirectionally with devices outside the medical device, in particular the sensor device.
  • the grain communication device may be arranged to enable electromagnetic communication.
  • the control can be set up to carry out a detection of electrical signals of the sensor element and / or to carry out a buffering of measured values. A preprocessing or at least partial processing of these signals and / or measured values can also take place within the control.
  • An exchange of measured values with other devices can then take place via the wireless communication device, for example.
  • a reception of control commands can take place, for example by the control receiving instructions from an external device.
  • the wireless communication device can comprise a device for radio communication, that is to say communication via electromagnetic waves in the high-frequency range, for example in the gigahertz range.
  • wireless communication can also take place, for example, via an inductive and / or electrical coupling.
  • the wireless communication can take place in such a way that no galvanic connection has to be established.
  • This is particularly advantageous in the case of electrochemical sensor devices having at least one invasive electrochemical sensor, in which the sensor electrodes preferably represent the only galvanic connection to the sensor device, without there being any further galvanic connection to the sensor device.
  • a slot structure is to be understood as meaning a structure having at least one slot in the metal housing, that is to say an elongate opening and / or interruption of the metal housing, which has a width and a length, the width considerably undershooting the length thereof.
  • the at least one slot may have a length which exceeds its width by at least a factor of 3, in particular by at least a factor of 5 or even at least a factor of 10 or preferably even at least a factor of 20.
  • the width of the slot is preferably less than 5 mm, more preferably 3 mm or less, or even only 1 mm or less.
  • An aspect ratio of the slot may in particular depend on the frequencies used and / or a radiation characteristic, if, as explained below, the slot is used as part of a slot antenna.
  • the slot can be configured as a simple, straight slot.
  • the slot may also be curved, bent or angled, with one or more straight or curved sections.
  • a meander structure is possible.
  • the slot structure may also be wholly or partially circular, ovalförmig or spirally designed.
  • a branched structure of the slot may be provided, with one or more branches.
  • the above-described condition on the slot geometry may then relate in particular to one or more or even all sections of the branched structure, wherein one or more sections may be provided which do not fulfill the said conditions, in particular one or more non-slit sections in addition to one or more slit sections.
  • the at least one slot thus preferably represents a break in the dielectric ratios of the metal housing, in particular if, as will be explained in more detail below, the slot is part of a slot antenna. About this fraction, a radiation of an electromagnetic wave from a predetermined line structure in this case, for example, from the metal housing.
  • the communication device is configured to communicate through the slot structure with at least one external device.
  • a communication through the slot structure can be understood on the one hand, that the communication through the slot structure through, for example, signals are transmitted through the slot structure from the interior of the housing in an outdoor area or emitted directly from the slot structure, for example by at least one Emitter is arranged in the slot structure.
  • the concept of a communication through the slot structure may also include that the slot structure itself is involved in the communication, so that the communication takes place, for example, by means of the slot structure. Examples are explained in more detail below.
  • the communication with the external device should generally preferably be completely wireless, in particular in order to avoid a galvanic coupling.
  • the housing should comprise the at least one metal housing.
  • the control is preferably at least partially disposed in the metal housing, in particular completely. This can be done, for example, that at least the electronic component, preferably at least one stralilenadedes electronic semiconductor device, is arranged completely or partially in the metal housing.
  • the metal housing completely or partially surround the control.
  • the metal housing may be arranged relative to the electronic component such that, viewed from the electronic component, the metal housing covers at least a solid angle of at least 2 ⁇ about the electronic component, preferably a solid angle of at least 2.5 ⁇ , more preferably a solid angle of at least 3 ⁇ and ideally a solid angle of at least 3.5 ⁇ or even 4 ⁇ .
  • the sensor element may in particular, as stated above, comprise at least one electrochemical sensor, with at least two, preferably at least three, in the implanted state of the sensor element in a body tissue of a user arranged sensor electrodes.
  • the control can then in particular comprise at least one potentiostat and / or at least one primary amplifier which can be connected or connected to the sensor electrodes.
  • One or more of these components may in particular form a so-called Analog Front End (AFE).
  • AFE Analog Front End
  • a potentiostat is to be understood as meaning an electronic control amplifier with which a potential of one of the electrodes can be regulated to a desired value.
  • the potentiostat may include a precise DC voltage source.
  • the potentiostat may be configured to adjust a current between a working electrode of the sensor element and a counter electrode of the sensor element so that the desired potential is achieved.
  • a reference electrode whose potential is defined in the electrochemical voltage series can be used as the reference point.
  • a primary amplifier can be understood to mean any amplifier which is directly or indirectly is applied directly with a signal of the sensor electrodes.
  • it may be a high-impedance input stage, wherein the amplifier may generally have a gain greater than 1, less than or equal to 1.
  • the input stage may have an input resistance which is comparatively high, for example in the range greater than 100 kohms, for example greater than 10 megohms or even greater than 1 gigaohm.
  • the sensor device can be set up in particular in such a way that the potentiostat and / or the primary amplifier, which can be completely or partially configured as semiconductor components, can be arranged in the metal housing.
  • further electronic components may also be arranged within the metal housing, for example memory components, operational amplifiers, transistors or other electronic components.
  • An arrangement in the metal housing is to be understood in general as an arrangement in which the metal housing shields the recorded components in at least one direction, so that ionizing radiation, as used for sterilization, can not penetrate to these components.
  • the metal housing may have a convex and a concave side, wherein the components may be arranged, for example, on the concave side of the metal housing.
  • the metal housing can form a metal shell shielding the control in at least one direction. Under a metal shell is to be understood as a opened in one direction shell structure.
  • the metal housing may in particular be hermetically coupled to a carrier element, in particular to a printed circuit board, wherein the carrier element carries the at least one electronic component of the drive.
  • the carrier element can be designed as a circuit carrier, in particular as a printed circuit board, on which the electronic component is applied, the metal housing being coupled to the circuit carrier, in particular to the printed circuit board.
  • a hermetic coupling is to be understood as meaning a coupling which prevents moisture from penetrating into a gap between the carrier element and the metal housing. This hermetic coupling can be done, for example, by potting and / or bonding.
  • the metal housing can shield the printed circuit board in one direction, for example in a direction which serves as an irradiation direction during sterilization.
  • the functional element preferably the sensor element, in particular the sensor electrodes, can preferably be arranged completely or partially outside the housing, for example for implantation in the body tissue.
  • the functional element, in particular the sensor element can in principle be connectable or connected to the control, for example detachably, for example via at least one plug connection. However, it is preferred if the functional element, in particular the sensor element, is firmly connectable or connected to the control.
  • the functional element, in particular the sensor element is preferably connected to the control without a plug connection and can not be separated from the control by a user in a non-destructive manner.
  • the functional element, in particular the sensor element can be permanently wired to the drive.
  • control and the functional element in particular the sensor element, can in particular be configured overall as a disposable or disposable part, for example for a wearing period of several weeks to several days.
  • the communication device is arranged to communicate through the slot structure with at least one external device.
  • this communication can be carried out in a basically arbitrary manner, in which the slot structure is involved in the communication.
  • at least one communication element of the grain communication device can be introduced into the slot structure and / or into at least one slot of the slot structure.
  • at least one coil can be introduced into the slot structure, via which device it is possible to communicate with an external device, with a transfer of electromagnetic waves and / or, for example, an inductive coupling through the slot structure or into the slot structure.
  • inductive and / or magnetic and / or capacitive couplings by means of at least one slot structure into consideration for example by one or more inductive and / or magnetic and / or capacitive coupling elements are introduced into or brought into the at least one slot structure in the metal housing.
  • the slot structure comprises at least one slot antenna.
  • the communication device can be set up to perform and / or enable wireless communication and / or electromagnetic communication, for example radio communication, by means of the slot antenna.
  • This electromagnetic communication may in particular be such that electromagnetic waves, in particular in the context of a free-field radiation according to the Maxwell field equations, emanate from the slot antenna and / or from the slot antenna are received.
  • the communication device and the slot antenna can thus be set up and cooperate in such a way that the slot antenna is used as an antenna for emission and / or reception of electromagnetic waves.
  • the proposed medical device and in particular the Sensorvorangung differs significantly, for example in this embodiment compared to above US 5,394,882 in which only an opening is provided in a metallization, which itself does not act as an antenna, but only as entrance window or exit window high-frequency waves serves.
  • a slot antenna is to be understood as an interruption in a metallic structure, in this case an interruption of the metal housing, via which electromagnetic waves can be emitted with suitable excitation.
  • this slot antenna may have a dipole or half dipole structure. Even more complex geometries are possible in principle. While antennas as part of the communication device are generally realized by metallic structures in air or on a carrier substrate, electromagnetic waves do not usually enter or leave metallic shields, such as the metal housing, due to their effect as Faraday cage.
  • electromagnetic waves are then emitted and / or received when, in an otherwise homogeneous structure, for example in this case the structure of the metal housing, a break in the dielectric and / or magnetic field conditions is caused.
  • This is exploited in the slot antenna, which operates on the Babinet principle, by breaking a metallic structure through one or more slots of suitable length and / or geometry.
  • a slot is defined as an opening in the metallic structure, in this case in the metallic housing, which has a high aspect ratio, ie a high ratio of length to width.
  • Slot antennas as used in the context of the present invention for the medical device and in particular the sensor device, are basically known from the prior art.
  • slot antennas are commonly used in aircraft as antennas.
  • a radiation of waveguides with slot structure is described for example in EP 1 263 086 A2.
  • Slot antennas provide many significant advantages to the present application and are ideally suited to solve the above-described object and technical dilemma of known devices.
  • the metal housing can be maintained, which provides a shielding of sensitive semiconductor components with respect to the sterilization radiation.
  • the functional element, in particular the sensor element, and the Control firmly connected or connected to each other and then sterilized, which provides significant production advantages. Nevertheless, radiation damage to the semiconductor devices are avoided.
  • the slot geometry of the slot antenna can be chosen such that either ionizing radiation can not penetrate into the interior of the metal housing, or the slot geometry and the position of the slots can be chosen such that there are no sensitive semiconductor devices below the slot antenna inside the metal housing, to which the ionizing radiation of the sterilization radiation could pass through the slot antenna.
  • the slot antenna may in turn comprise one or more slots which may be opened and / or filled with air or other gas, which however may preferably also be sealed, for example with a dielectric material.
  • the dielectric material may be present as a solid.
  • the dielectric material may be or include at least one plastic material, such as an epoxy resin and / or a polyurethane.
  • the dielectric material should have a permittivity or a dielectric coefficient ⁇ ⁇ which is preferably close to one, for example a dielectric coefficient of ⁇ 5, in particular ⁇ 3, preferably ⁇ 2 or even ⁇ 1.5.
  • the slot is therefore only in the metal housing and thus represents an interruption of the otherwise homogeneous structure of the metal housing, wherein the filling of the slot with the dielectric material does not or only slightly influences the antenna properties of the slot antenna.
  • the aspect ratio essentially a passage of ionizing radiation through the slot structure into the interior of the housing can be prevented.
  • slot antennas are already known from other fields of technology.
  • slot antennas are known from transponder technology in recent times.
  • WO 2007/048589 A1 describes a transponder chip module for a transponder with slot antimatter.
  • the transponder chip module has a transponder chip and thus electrically connected contact points, which are arranged on mutually facing away surfaces of the transponder chip module.
  • Slot antennas are also known in principle from RFID technology and packaging technology, for example, existing metallizations, eg for moisture insulation in drug blisters or so-called smart packs with suitable slot structures be provided, which act as antennas.
  • An example of a slot antenna structure suitable for RFID technology is described in WO 03/0921 16 A2. If an RFID chip is connected to such slot antennas, the result is, as described above, a transponder. Smart packages provided with such transponders can store and / or modify data or even operate sensors, such as temperature sensors, humidity sensors or the like.
  • the communication device may in particular comprise at least one excitation device which is set up to excite the slot antenna to emit electromagnetic waves.
  • excitation devices For the design of such excitation devices, reference may be made to known slot antennas or also to the WO 2007/048589 A1 described above.
  • the excitation of the slot antenna can for example be wired or wireless.
  • an electromagnetic resonant circuit may be provided, which is electrically conductive (for example via one, two or more of the excitation device to the metal housing and / or the slot structure connecting conductor) or wirelessly, for example by means of a disposed within the metal housing primary emitter, the slot antenna for emitting electromagnetic Can stimulate waves.
  • the excitation device may also comprise at least one inductive element for shortening a slot length of a slot of the slot antenna to a length of not more than 10 cm.
  • This inductive element may comprise, for example, a coil or other type of inductive element in a connection between the excitation device and / or an oscillator of the excitation device and the slot antenna.
  • the slip-seat structure may have a slot having a slot length of not more than 10 cm, preferably not more than 5 cm, and more preferably not more than 1 cm, preferably even less than 1 cm. If a slot antenna is used, then, as stated above, it may in principle have any desired geometry.
  • linear geometries can be used, in particular dipole and / or semi-dipole geometries.
  • Other geometries are possible in principle, for example, branched geometries.
  • fractal geometries can also be used.
  • Such fractal geometries may include a plurality of slots, for example a plurality of branched slots which are angled relative to each other and form, for example, a fractal pattern.
  • Fractal geometries are basically known from the field of printed, ie non-slotted antennas, for example from EP 1 326 302 A2. In principle, such fractal geometries can also be used in the context of the present invention for the slot structure and in particular for the slot antenna.
  • the slot structure can continue to be at least partially connected to a dielectric sealed material.
  • the at least one slot can be completely or partially filled with a dielectric material which completely or partially seals the interior of the housing.
  • the dielectric material can be chosen such that it has a dielectric coefficient ⁇ , which is much different (in its real part and / or its imaginary part) from that of the material of the metal housing, for example by at least a factor of 1.5, preferably in order
  • the dielectric material may comprise at least a factor of 2 and more preferably even at least a factor of 3.
  • the dielectric material may comprise at least one plastic material.
  • the metal housing may have a shielding effect for sterilizing radiation, in particular for ionizing radiation.
  • radiation sterilization can be used, in particular using ionizing particle radiation and / or ionizing electromagnetic radiation, for example selected from alpha radiation, beta radiation, gamma radiation, X-radiation and electron radiation.
  • ionizing particle radiation and / or ionizing electromagnetic radiation for example selected from alpha radiation, beta radiation, gamma radiation, X-radiation and electron radiation.
  • electron beam sterilization is frequently used.
  • the electron beams typically have a beam energy between 3 MeV and 12 MeV, with a typical sterilization dose of 25 kGy.
  • the metal housing of the medical device in particular the sensor device, can accordingly have a shielding effect, which for electron radiation between 3 and 12 MeV is at least a factor 2, preferably at least a factor 5 and particularly preferably at least a factor 10 or even a factor 20 or 50.
  • a radiation dose of originally 25 kGy can be reduced to a maximum of 12.5 kGy, preferably 5 kGy and particularly preferably at most 2.5 kGy, at most 1.25 kGy or even at most 0.5 kGy.
  • the latter takes into account the fact that, for example, conventional CMOS electronics typically do not suffer permanent damage or consequential damage at radiation doses of 0.5 to 1 kGy.
  • the metal housing may comprise at least one metal selected from one of the following metals: aluminum; Iron; Lead; Copper; a precious metal, especially gold, silver, platinum; an alloy. Combinations of said and / or other metals or elements are conceivable.
  • the metal housing may have a thickness which is at least 0.5 mm, preferably at least 1 mm or even at least 2 mm.
  • the metal case does not have to wrap around all of the drive but should only be sensitive to radiation semiconductor devices shield that they are protected in a radiation sterilization, preferably in a directed, anisotropic radiation sterilization.
  • the metal housing may be configured as a half shell. As indicated above, the proposed slot structure interrupts the Ab shielding effect only insignificantly.
  • the slot structure may, in particular, have at least one slot which is geometrically configured and / or arranged such that ionizing beams entering the housing through this slot do not strike sensitive semiconductor components during radiation sterilization.
  • the slot structure may comprise at least one slot
  • the drive may comprise at least one printed circuit board, which may for example be wholly or partially rigid and / or flexible, the electronic component, in particular at least one electronic semiconductor component, preferably all electronic semiconductor components the circuit board is located outside a vertical projection of the slot on the circuit board or are.
  • the slot structure may have at least one slot, wherein a border of the slot may span a plane.
  • This clamping can be done, for example, by defining the plane such that either all the points of the border lie on the plane, or that a sum of the squares of the distances between all points of the border and the plane becomes minimal.
  • the border of the slot itself may be designed just flat or curved.
  • the drive can have at least one carrier element, wherein the electronic component is arranged on the carrier element outside a projection of the slot, the projection being a projection perpendicular to the plane onto the carrier element.
  • the support element does not necessarily have to be designed flat.
  • the carrier element may comprise at least one planar circuit carrier, for example at least one printed circuit board.
  • non-planar circuit carriers can also be used, for example so-called three-dimensional circuit boards.
  • Non-planar circuit carriers can be produced, for example, by means of injection molding and / or by means of so-called Molded Interconnect Device (MID) technologies.
  • MID Molded Interconnect Device
  • the support member may be wholly or partially different from the housing.
  • the carrier element can be incorporated as an independent component wholly or partly in the housing.
  • the carrier element can also be wholly or partially connected to the housing or even be integrally formed with the housing or parts thereof.
  • the at least one electronic component can also be applied completely or partially directly on the housing.
  • the medical device and in particular the sensor device is even designed such that even within an angle of incidence of ⁇ 5 °, in particular of ⁇ 10 ° and particularly preferably of ⁇ 20 ° in the housing no electronic component is arranged.
  • the slot structure may have at least one slot, wherein a border of the slot in the sense of the above definition spans a plane, wherein the electronic component is arranged outside a region which is formed as the sum of cones, wherein conical points of the cones are points the edges of the slot are, wherein cone axes of the cones are perpendicular to the plane and wherein the cones have an opening angle of 10 ° (corresponding to a deviation of ⁇ 5 ° from a vertical projection), in particular 20 ° (corresponding to a deviation of ⁇ 10 ° of a vertical projection) and more preferably 40 ° (corresponding to a deviation of ⁇ 20 ° from a vertical projection).
  • the slot structure may have at least one projecting into the interior of the metal housing metallic shielding.
  • This shielding element may, for example, comprise a collar which projects into the interior of the metal housing.
  • This shielding collar or shielding element can cause possibly ionizing radiation to be able to enter through the opening of the slot structure, but then strike the shielding element where it is either absorbed or directed in a direction in which no sensitive semiconductor components are arranged.
  • the at least one shielding element or the at least one shielding collar can also be designed as a radiation trap and / or comprise a radiation trap.
  • the housing can be designed in particular moisture-proof. This can be done for example by appropriate sealing elements and / or a corresponding potting.
  • the metal housing may be hermetically coupled to a carrier element, in particular a circuit carrier and particularly preferably a printed circuit board, wherein the carrier element is the electronic component. element bears.
  • the metal housing may be placed on the carrier element as a metal shell and, for example, encapsulated with the carrier element or sealed in some other way, for example by gluing.
  • the functional element, in particular the sensor element is preferably connectable or connected to the drive.
  • At least one supply line of the functional element, in particular of the sensor element can be guided into the housing by at least one sealing element and can be connected or connected to the control there.
  • This at least one sealing element may comprise, for example, a sealing lip and / or another type of elastomeric seal and / or a bond.
  • the control can be completely or partially configured separately from the functional element, in particular the sensor element, but can also be completely or partially connected to the functional element, in particular the sensor element, connectable or integrally formed with the functional element, in particular the sensor element be.
  • at least one substrate of the functional element, in particular of the sensor element can also be used at the same time as the substrate of the control.
  • a flexible printed circuit board or flex line can be used, which can form the functional element, in particular the sensor element, or at least a part thereof and at the same time the drive or a part thereof, for example a substrate of the drive.
  • the flex line or the flexible printed circuit board for example, outside the housing with at least one cover, for example, at least one Abdecklack be provided, the cover may be formed separately from the optional sealing element and separate from the housing, but also a preferably seamless transition between the cover and the housing may be provided, for example by the functional element, in particular the sensor element, and / or its cover immediately and without breaking edge pass into the sealing element and / or the housing.
  • a method for producing a medical device in particular a sensor device, is proposed.
  • it may be a medical device and particularly preferably a sensor device according to one or more of the embodiments described above or below.
  • the medical device in particular the sensor device
  • other embodiments of the medical device and in particular the sensor device are in principle possible.
  • at least one implantable functional element, in particular at least one implantable sensor element, and at least one drive with at least one electronic component are provided. This can be done, for example, under sterile conditions, for example in a sterile room. On the other hand, an assembly can preferably take place outside the sterile room.
  • the functional element in particular the sensor element, can be connected to the drive, which in turn also implies the possibility that the connection of the functional element, in particular of the sensor element, with the drive is part of the method according to the invention.
  • This method step of connecting the functional element, in particular the sensor element, with the control can also be carried out completely or partially under sterile conditions.
  • the connection can be made, for example, by connecting two or more electrode leads for electrodes of the functional element, in particular of the sensor element, to corresponding components of the control, for example a potentiostat and / or a primary amplifier.
  • the drive is completely or partially shielded by a housing with at least one metal housing.
  • the housing and / or the metal housing is placed after connecting the functional element, in particular the sensor element, with the control on one or more components of the control and / or applied to a carrier element of the control, wherein the control completely or partially enclosed.
  • the shielding of the drive through the housing can also be done under sterile conditions. Under a shield is an at least largely moisture-tight partitioning of one or more components of the control to understand, in particular the at least one electronic component.
  • at least partial shielding from ionizing radiation, in particular electron radiation and / or beta radiation takes place through the metal housing.
  • the driver has at least one wireless communication device.
  • the metal housing has at least one slot structure, wherein the communication device is configured to communicate through the slot structure with at least one external device.
  • this can take place in that at least one slot, in particular at least one slot antenna, is introduced into the metal housing before or after the production of the shield.
  • a slot antenna is provided, then a suitable coupling of the communication device to the slot antenna is preferably provided, for example by a corresponding conductive or wireless connection between an excitation device of the communication device and the slot antenna.
  • Radiation sterilization by the ionizing radiation may generally comprise radiation sterilization with electromagnetic radiation and / or particle radiation.
  • electromagnetic radiation for example, alpha, beta, gamma, x-ray or electron beams may be used for this purpose, with no distinction being made below between electron beams and beta rays. Combinations of the types of radiation mentioned can also be used.
  • the use of ionizing radiation has the advantage that in particular sensitive electrodes of the sensor element are not or only slightly affected by chemical influences.
  • the radiation sterilization with ionizing radiation can be carried out in particular by using anisotropic ionizing radiation, for example by the ionizing radiation being directed onto the medical device, in particular the sensor device.
  • the selection of this irradiation direction is such that during irradiation, the metal housing between the radiation source and the at least one electronic component, in particular the at least one radiation-sensitive semiconductor device, is arranged.
  • a metal housing in the form of a shell or half shell this can be done, for example, in such a way that the shell or half shell covers the at least one electronic component in a dome-like manner and peels off the radiation, whereas, for example, other areas of the medical device, in particular the sensor device, are accessible to the radiation are.
  • the production of the assembly or the medical device and in particular the sensor device can take place in particular under non-sterile conditions, for example outside a sterile room.
  • the radiation sterilization can then take place, for example, in a state in which the medical device, in particular the sensor device, is already packaged, for example in a blister pack.
  • the medical device in particular the sensor device
  • the sensor device can be manufactured non-sterile, subsequently packaged in, for example, a blister pack or other germ-proof packaging, and then sterilized in such a way that the sterilizing radiation penetrates the packaging.
  • the direction of irradiation of the ionizing radiation onto the housing can in particular be chosen such that ionizing radiation entering the housing through the slot structure does not reach the at least one electronic component or at least sensitive electronic components of the drive, for example sensitive semiconductor components.
  • an irradiation direction can be understood to mean, in particular, a spatial direction from which the ionizing radiation impinges on the housing.
  • Embodiment 1 Medical device for carrying out at least one medical function on a human or animal body, in particular a sensor device for monitoring at least one body function, in particular for detecting at least one analyte in a body fluid wherein the medical device uxntinet at least one implantable functional element, in particular at least one implantable sensor element, and at least one control with at least one electronic component, wherein the functional element is connectable to the drive, wherein the control comprises a housing having at least one metal housing, wherein the control at least a wireless communication device, wherein the metal housing has at least one slot structure, wherein the communication device is arranged to communicate through the slot structure with at least one external device.
  • Embodiment 2 Medical device according to the preceding embodiment, wherein the drive is arranged at least partially in the metal housing.
  • Embodiment 3 Medical device according to one of the preceding embodiments, wherein the medical device comprises a sensor device, in particular a sensor device for monitoring at least one body function and / or a sensor device for detecting at least one analyte in a body fluid, and wherein the functional element at least one implantable Sensor element comprises, in particular at least one implantable sensor element for detecting at least one analyte in a body fluid.
  • the medical device comprises a sensor device, in particular a sensor device for monitoring at least one body function and / or a sensor device for detecting at least one analyte in a body fluid
  • the functional element at least one implantable Sensor element comprises, in particular at least one implantable sensor element for detecting at least one analyte in a body fluid.
  • Embodiment 4 Medical device for carrying out at least one medical function on a human or animal body, in particular a sensor device for monitoring at least one body function, in particular according to one of the preceding embodiments, in particular for detecting at least one analyte in a body fluid
  • the medical device comprises at least one implantable functional element includes, in particular at least one implantable sensor element, wherein the medical device further comprises at least one drive with at least one electronic component, wherein the functional element is connectable to the drive, wherein the drive is a housing with at least at least one metal housing, wherein the metal housing is made entirely of a metallic material, wherein the drive is at least partially disposed in the metal housing, wherein the metal housing surrounds the control completely or partially, wherein the control has at least one wireless communication device wherein the wireless communication device comprises a device for communication selected from the group consisting of radio communication, inductive coupling communication, and electrical coupling communication, wherein the metal housing has at least one slot structure, the communication device being configured to through the slot structure to communicate with at least
  • Embodiment 5 Medical device according to the preceding embodiment, wherein the medical device comprises a sensor device, in particular a sensor device for monitoring at least one body function and / or a sensor device for detecting at least one analyte in a body fluid, and wherein the functional element at least one implantable sensor element comprises, in particular at least one implantable sensor element for detecting at least one analyte in a body fluid.
  • the medical device comprises a sensor device, in particular a sensor device for monitoring at least one body function and / or a sensor device for detecting at least one analyte in a body fluid
  • the functional element at least one implantable sensor element comprises, in particular at least one implantable sensor element for detecting at least one analyte in a body fluid.
  • Embodiment 6 Medical device according to one of the preceding embodiments, wherein the functional element, in particular the sensor element, comprises at least one electrochemical sensor with at least two sensor electrodes arranged in a body tissue in the implanted state of the functional element, wherein the control comprises at least one potentiostat and / or has at least one connected to the sensor electrodes primary amplifier, wherein the potentiostat and / or the primary amplifier are arranged in the metal housing.
  • Embodiment 7 Medical device according to one of the preceding embodiments, wherein the metal housing forms a metal shell shielding the drive in at least one direction.
  • Embodiment 8 Medical device according to one of the preceding embodiments, wherein the metal housing is hermetically coupled to a carrier element, in particular a printed circuit board, wherein the carrier element carries the electronic component.
  • Embodiment 9 A medical device according to one of the preceding embodiments, wherein the slot structure comprises at least one slot antenna.
  • Embodiment 10 The medical device according to the preceding embodiment, wherein the communication device comprises at least one excitation device, wherein the excitation device is arranged to excite the slot antenna to emit electromagnetic waves.
  • Embodiment 11 Medical device according to one of the preceding embodiments, wherein the slot structure is at least partially sealed with at least one dielectric material.
  • Embodiment 12 The medical device according to one of the preceding embodiments, wherein the metal housing has an Able Sign for electron radiation between 3 and 12 MeV by at least a factor of 2, preferably by at least a factor of 5 and more preferably by at least a factor of 10.
  • Embodiment 13 Medical device according to one of the preceding embodiments, wherein the metal housing comprises at least one metal selected from one of the following metals: aluminum; Iron; Lead; Copper; a precious metal; an alloy.
  • Embodiment 14 The medical device according to one of the preceding embodiments, wherein the slot structure has at least one slot, wherein a circumference of the slot spans a plane, wherein the drive comprises at least one carrier element, wherein the electronic component on the carrier element outside a projection of the slot is arranged, wherein the projection is a projection perpendicular to the plane on the support element,
  • Embodiment 15 Medical device according to the preceding Ausbowungs- form, wherein the support member is a circuit board.
  • Embodiment 16 Medical device according to one of the preceding embodiments, wherein the slot structure has at least one metal shielding element extending into the interior of the metal housing, in particular a shielding collar.
  • Embodiment 17 Medical device according to one of the preceding embodiments, wherein the functional element, in particular the sensor element, is fixedly connected to the Ansteuemng, wherein at least one supply line of the functional element is guided by at least one sealing element in the housing.
  • Embodiment 16 Method for producing a medical device, in particular a sensor device, in particular a medical device according to one of the preceding embodiments, wherein at least one implantable functional element, in particular at least one implantable sensor element, and at least one drive with at least one electronic component are provided, wherein the functional element is connectable to the drive, wherein the drive is shielded by a housing having at least one metal housing, wherein the drive comprises at least one wireless Konimunikationsvorraum, wherein the metal housing has at least one slot structure, wherein the Kornmunikationsvorrich- device is set to by the Slot structure with at least one external device to communicate, wherein the medical device is sterilized with at least one ionizing radiation.
  • Embodiment 17 Method for producing a sensor device, in particular according to one of the preceding embodiments relating to a sensor device, wherein at least one implantable sensor element and at least one drive are provided with at least one electronic component, wherein the sensor element can be connected to the drive, wherein the drive is shielded by a housing having at least one metal housing, wherein the metal housing is made entirely of a metallic material, wherein the drive is at least partially disposed in the metal housing, wherein the metal housing surrounds the drive completely or partially, wherein the drive comprises at least one wireless Lichtumkationsvorraum wherein the wireless communication device comprises a device for communication selected from the group consisting of radio communication, communication via an ind comprising at least one slot structure, wherein the communication device is arranged to communicate through the slot structure with at least one external device so that the communication takes place by means of the slot structure, wherein the sensor device comprises tion with at least one ionizing radiation is sterilized.
  • the wireless communication device comprises a device for communication selected from the group consisting of radio communication
  • Embodiment 18 Method according to one of the two preceding embodiments, wherein an anisotropic ionizing radiation, in particular a beta radiation, is used, wherein an irradiation direction of the ionizing radiation on the housing is selected such that ionizing radiation entering the housing through the slot structure forms the electronic component not reached.
  • an anisotropic ionizing radiation in particular a beta radiation
  • the above-proposed medical device, in particular the sensor device, and the method for producing a medical device, in particular a sensor device have numerous advantages over known medical devices and production methods.
  • an optimal seal and shield at the same time the possibility of wireless communication between the control and at least one external Device via the communication device, preferably by means of the slot antenna to provide.
  • plastics Due to their molecular structure, plastics generally have a comparatively high degree of fire-propagation, as a result of which water and water vapor penetrate into the plastic housing after a relatively short time (usually within hours to days) and are there usually to be desired parasitic leakage currents can drive the control. According to the prior art, correspondingly high expenditures for the optimization of the density are required, for example in the form of multilayer structures or desiccant depots inserted therebetween. In addition, plastic injection molding is often used. However, wall thicknesses below 1 mm are usually difficult to control. Therefore, conventional, the prior art and in particular multi-layer housing, however, are usually comparatively thick-walled and thus large. This is all the more significant because implanted or partially implanted systems should be designed as small and lightweight as possible because of adequate wearing comfort.
  • metals have the advantage of significantly lower permeation and, at the same time, are able to attenuate sterilizing radiation.
  • the control in particular a potentiostat and / or a primary amplifier, for reasons of processing relatively small signals and hermetically isolate the high insulation requirements to the outside world and yet arrange close to the functional element, in particular close to the sensor element.
  • the metal housing offers a shield against ionizing radiation, the functional element, in particular the sensor element, can be simultaneously radiation-sterilized, since electronic components of the drive are protected by the metal housing. A system interface can be omitted.
  • medical devices in particular sensor devices, which can be designed as full implants, ie medical devices and in particular sensor devices in which both the functional element, in particular the sensor element, and the drive connected thereto are completely implanted in a body tissue of the user can be.
  • These solid implants may include chemically reactive electrodes.
  • the full implants can be sterilized without the risk of radiation damage.
  • Figure 1 shows a first embodiment of a sensor device according to the invention with separable by connectors sensor element and control;
  • FIGS. 2A and 2B an embodiment of a sensor device with permanently connected sensor element and control
  • FIGS. 3A and 3B show an exemplary embodiment of a fully implanted sensor device with an external reading device
  • Figure 4 shows an embodiment of a sensor device with a flexible
  • FIG. 1 schematically shows a first exemplary embodiment of a sensor device 110 according to the invention for monitoring at least one body function, here in particular for detecting at least one analyte in a body fluid.
  • the sensor device 110 serves as an exemplary embodiment of a medical device 111 for carrying out at least one medical function on a human or animal body.
  • the sensor device 110 initially corresponds structurally to a large extent to the sensor device described in EP 1 972 269 A1 and comprises a disposable 112, that is to say a disposable part, and a reusable 114, that is to say a reusable part.
  • the disposable 112 includes In the illustrated embodiment, a sensor element 116.
  • the sensor element 116 generally represents an embodiment of an implantable functional element 117.
  • the sensor element 116 may include, for example, a flexible support 118, such as a film carrier, and two, three or more electrodes 120 for electrochemical analyte detection.
  • the disposable 112 comprises an electronic part 122 with a power supply, for example in the form of a battery 124, and a storage element 126, for example in the form of an EEPROM.
  • the storage element 126 may include, for example, lot-specific data for the sensor element 116.
  • the disposable 112 is connected in the illustrated embodiment via connectors 128 to the Reusable 114.
  • This connector 128 may include, as optionally one or more other connectors of the sensor device 110, at least one sealing element 129, which may be part of the connector 128 and / or a housing 142 and / or other components or which also completely or partially as a separate component can be trained.
  • the reusable 114 may in particular comprise a component which is designated in FIG. 1 with "AFE" (analogue front-end) and which may comprise, for example, a potentiostat 130 and / or a primary amplifier 132 with high input resistance.
  • AFE analogue front-end
  • the reusable 114 can include a data processing device 134, which can be set up, for example, for a measurement data evaluation or at least a preliminary measurement data evaluation.
  • the data processing device 134 is designated in FIG. 1 as a microcontroller (pC).
  • the data processing device 134 may have its own memory or may, alternatively or additionally, access the memory element 126 of the disposable 112.
  • the reusable 1 14 comprises a communication device 136. In the illustrated exemplary embodiment, this is configured as a high-frequency (RF) communication device 136, for example as a radio chip.
  • RF high-frequency
  • the disposable 112 may include, for example, a bottom plate 138 or another type of support element adjacent to the sensor element 116, which may comprise the battery 124 and the battery Memory element 126, for example, a memory chip contains.
  • This example shows that the drive 140 can also be designed in several parts.
  • the disposable 112 is usually only used for one wearing cycle, for example for one week.
  • the reusable 114 together with the disposable 112 provides the operative patch of the sensor device 110.
  • the reusable 114 is preferably configured for multiple use, for example, for more than 50 cycles and / or for one year use.
  • the insulation resistances within the entire electrical circuit therefore generally have to be comparatively high, for example more than 10 12 ohms or even more than 10 13 ohms.
  • the electronic modules of the disposable 112 and the reusable 114, so the driver 140 received in housings 142.
  • These housings 142 are designed, for example, completely or partially as a metal housing 144.
  • metal housing 144 may be provided in the form of metal cups. These metal cups can be produced, for example, by means of customary metal processing methods, for example embossing and / or deep-drawing.
  • the electronic components 126, 130, 132, 134 and 136 or parts of these electronic components can be applied to one or more carrier elements 146, for example one or more printed circuit boards.
  • the assembled printed circuit boards can be introduced into the metal housing 144.
  • a seal can be made, for example via a potting and / or bonding.
  • the sensor device 110 according to FIG. 1 produced in this way can then be sterilized by radiation as a whole.
  • beta radiation is usually used in radiation sterilization.
  • beta radiation depends on the density of the material.
  • beta radiation is used between 3 MeV and 12 MeV, using typical 25 kGy radiation doses.
  • Beta radiation of an intensity of 10 MeV for example, penetrates Iron approx. 6 mm, aluminum approx. 19 mm. Accordingly, iron is preferable as the material for the metal shell 144.
  • Copper is also very effective, which at the same time absorbs the secondary radiation (X-ray bremsstrahlung) that occurs during beta radiation.
  • a copper screen of 3 mm thickness is sufficient to sufficiently attenuate the radiation at 25 kGy. Good compromises in shielding performance, workmanship and weight generally form as materials aluminum and copper. In principle, however, other materials and compounds of different materials can be used. Thus, for example, an aluminum layer would have the function of attenuating beta rays, whereas a second layer of a heavy metal, for example lead, would cause the damping of the bremsstrahlung.
  • a thin shell of a suitable polymer could be provided which provides the function of biocompatibility, as heavy metals are generally not biocompatible.
  • metal housing 144 need not be made entirely of one and the same material.
  • metal housings with a plurality of materials, and metal housings which have a multilayer structure.
  • metallic materials with non-metallic materials.
  • the embodiment of the sensor device 110 shown in FIG. 1 is a so-called continuous monitoring sensor. In principle, however, it is also possible with the present invention to derive analyte sensors or physio-physical sensors as well as actuators and combinations of such devices.
  • the connectors 128 are preferably passed through the metal housing 144 by means of plastic sleeves.
  • the surfaces of the bushings are preferably designed to be small in relation to the total area of the metal cups or metal housings 144.
  • the plug region is likewise hermetically sealed, for example by means of detachable seals, in particular by means of O-rings.
  • conventional plug systems such as e.g. Poco contacts or blade contacts are used.
  • Other embodiments are possible.
  • the Reusables 114 ie in the desired direction of radiation for radio signals, is therefore in the illustrated embodiment a Slot structure 148 introduced.
  • This slot structure 148 acts in the illustrated embodiment, in particular as a slot antenna 150 with an elongated slot 152, which is shown in the illustrated embodiment as an angled slot.
  • slot geometries are possible in principle.
  • the slot antenna 150 is acted upon by a not shown in Figure 1 excitation device 154 of the communication device 136 with high-frequency signals and excited to emit radio waves outside of the metal housing 144.
  • the plan view according to FIG. 1 shows that the slot antenna 150 or the slot 152 is preferably arranged such that they are not located above sensitive electronic components, for example the components 130, 132, 134, 136. In this way, the The likelihood that rays entering the slot 152 due to radiation sterilization will damage these devices reduces.
  • other positions of the slot antenna 148 are possible, for example, positions closer to the body. However, these are generally not optimal with respect to their emission and / or reception characteristics. In order to obtain the best possible reception and / or emission characteristic, different slot structures 148 are also possible.
  • slot structures 148 can be optimized, so that, for example, spirals, meanders or similar structures can be used.
  • dimensions of the antenna structure can be adapted to the frequencies and / or wavelengths used.
  • an antenna shortening can take place in this way.
  • the excitation device 154 and / or the slot structure 148 itself may include one or more inductors. Because of the demand for the smallness of such a system, high frequencies are generally better suited than low frequencies because of the shorter wavelengths. With the widespread, freely available ISM frequency of 2.4 GHz worldwide, slot structures with a length of only a few cm are created. These can be shortened even further by suitable inductors. In principle, however, other wavelengths are possible.
  • the slot 152 of the slot structure 148 can also be filled with an insulating and / or sealing mass.
  • this may be a polymer composition having a dielectric constant that is far different from the metal of the metal housing 144.
  • the low permeation of the overall housing is not or only insignificantly influenced because the permeation is, inter alia, a function of the area. Since the sensor device 110 shown in FIG. 1 can now also be sterilized without hesitation, FIGS. 2A and 2B show a second exemplary embodiment of a sensor device 110 as an example of a medical device 11 1, in which the connectors 128 and the subdivision of the sensor device 110 in a Disposable 1 12 and a Reusable 114 is waived.
  • the sensor element 1 16, as an example of a functional element 117, with the control 140 and there in particular with the AFE 130, 132 firmly connected and integrated.
  • a miniaturization and / or combination of a plurality of electronic components of the drive 140 may also take place, for example by forming a plurality of the illustrated components or even all of the illustrated components into a common integrated circuit and / or integrated semiconductor device, for example an ASIC (user-specific integrated circuit).
  • ASIC user-specific integrated circuit
  • FIG. 2B shows a sectional view through the sensor device 110 according to FIG. 2A from the side.
  • a body tissue 156 is also shown, into which the sensor element 116 is partially implanted with its electrodes 120 side.
  • the metal housing 144 in the illustrated embodiment represents a half-shell, which is slipped over the support member 146, which carries all or at least some of the electronic components 130 to 136.
  • the half-shell is thus arranged so relative to the communication device s 136 that it is arranged in a possible emission direction for communication signals of a radio communication.
  • the half-shell can then be hermetically sealed by one or more seals 158 to the body tissue 156, for example by gluing and / or potting, so that the support element 146 can be arranged with the electronic components inside a hermetically sealed housing 142.
  • the carrier 118 of the sensor element 1 16 with correspondingly received leads can then be guided into the interior of the housing 142 by one or more sealing elements 160, which are not shown in detail in Figure 2B.
  • the slot structure 148 is arranged away from the electronic components 130 to 136.
  • Figure 2B is symbolically a Ray sterilization 162 indicated, which, however, is not done by nature when applied to the body tissue 156 sensor device 1 10, but already during manufacture and before use by a user.
  • the radiation sterilization 162 can in particular be anisotropic, with an irradiation direction oblique to a normal to the carrier element 146. Even if in this case rays of the radiation sterilization 162 should penetrate into the interior of the housing 142, they do not strike the electronic circuit board formed the carrier element 146 and the electronic components, for example 130 to 136. Radiation damage can be avoided in this way.
  • one or more shielding elements 164 can be provided, for example by the metal housing 144 being bent inwards in this area and forming a collar. In this way, rays entering through the opening of the slot 152 can also be absorbed in the interior of the housing 142 and / or deflected in a harmless direction.
  • the carrier 118 of the sensor element 16 and the carrier element 146 are designed as separate elements by way of example. However, this is not necessarily the case. Thus, in the exemplary embodiment illustrated in FIGS.
  • At least one carrier 118 of the sensor element 116 and at least one carrier element 146 of the control 140 can be completely or partially combined.
  • the carrier 118 which may also be referred to as a sensor substrate, wherein a plurality of such sensor substrates (for example in a layer structure) may be provided, also form a rigid or flexible circuit board as a carrier element 146 of the control 140 or a portion of the control 140 , An embodiment of such an arrangement is shown in FIG.
  • the exemplary embodiment can essentially correspond to the exemplary embodiment according to FIGS. 2A and 2B, so that reference can be made to the above description for the description of the individual elements. However, other embodiments are possible.
  • the carrier 118 of the sensor element 16 comprises a flexible printed circuit board, for example a flex line 184, which is simultaneously also felt in the housing 142 and serves there as the carrier element 146 of the control 140.
  • the flex line 184 may comprise, for example, on one or both sides one or more tracks 186 which may be connected to the electrodes 120 of the sensor element 116 and which may connect them to the driver 140.
  • the flex line 184 may, for example, be coated in the region of the sensor element 116 by one or more layers of a cover element 188, for example a topcoat 190, preferably in such a way that the electrodes 120 remain free.
  • the topcoat 190 or the cover element 188 may also optionally form the sealing element 129 or a part thereof at the transition to the housing 142.
  • the cover element 188 can pass directly into the sealing element 129 without breaking edge.
  • the cover element 188 may cover the sensor element 116 in whole or in part and may optionally also completely or partially cover the housing 142, for example by the cover lacquer 190 completely or partially covering the housing 142 and in particular the metal housing 144.
  • the cover element 188 may optionally also be a component of the housing 142 in this or also in other exemplary embodiments and, for example, provide a corrosion protection for the metal housing 144.
  • a sealing space 192 of the housing 142 remain free or even completely or partially filled with a filler 194, for example a dielectric filler 194.
  • a completely integrated medical device 111 in particular a completely integrated sensor device 110, which can also be designed, for example, as a full implant.
  • FIG. 3A shows a section of a metal housing 144 of the sensor device according to FIG. 3A in the region of a slot structure 148 in plan view.
  • the sensor device 110 represents a full implant, which can be completely implanted in the body tissue 156.
  • the sensor device 1 10 can basically be configured analogously to the sensor device, for example according to FIG. 2A.
  • functionalities of the control 140 can also be outsourced, in this exemplary embodiment by way of example to an external reading device 168.
  • the control 140 of the sensor device 110 can only be switched on AFE 130, 132 are reduced.
  • This can, as indicated in Figure 3A, additionally have an RFID functionality and thus already be part of a communication device 136.
  • the communication device 136 can in turn communicate via a slot antenna 150 with at least one external device, for example the reader 168.
  • FIG. 3A illustrates one way in which the slot structure 148 is utilized not as a slot antenna 150, but for the purpose of inductive data exchange with the reader 168.
  • a coil may be incorporated in the slot structure 148 or in the vicinity of the slot structure 148 170 are placed, for example, a coil 170, which is embedded in metal, which can be inductively replaced by the coil 170 signals with another coil 172 in the reader 168, through the slot structure 148 of Metal housing 144 through.
  • the coil 170 may be in the form of a copper wire and may be embedded, for example, in a dielectric material or filler 171, such as a sealing polymer, which may seal the slot 152.
  • the coil 170 may, for example, be contacted via terminals 169 and / or feedthroughs and be connected to the communication device 136, for example.
  • the metal housing 144 may be radiation sterilized during manufacture without the electronic components, in particular the AFE / RFID 130, 132 suffering radiation damage.
  • the reader 168 be outsourced.
  • the reader 168 may further include an RFID reader 164 to inductively receive, for example, measurement signals of the AFE 130, 132 via the coils 170, 172.
  • the inductive coupling between the coils 170, 172 may also be utilized, according to known RFID technologies.
  • the reader 168 may also include a communication hub 176, such as a radio frequency transmitter 178 and an antenna 180.
  • the reader 168 which need not necessarily be sterile, may have its own housing 182 which, due to the preferred location, is not external to the body tissue must necessarily be sterilized. Accordingly, the housing 182 can also be made of a non-metallic material, so that conventional antenna structures, alternatively or in addition to a slot structure, can also be used for the antenna 180. Alternatively or additionally, however, a slot antenna can preferably also be used for far-field communication between the reader 168 and another device, since the reader 168 may also have to satisfy biocompatibility requirements and may be sterilized.
  • the housing 182 can again be designed completely or partially as a metal housing.
  • implanting the antenna 180 for far-field communication under the skin is also possible in principle, it is practically difficult to achieve because high frequencies are strongly absorbed in the tissue and because accordingly long-wave frequencies would be necessary, which in turn would lead to disproportionately high antenna dimensions.

Abstract

L'invention concerne un dispositif médical (111) pour la détection d'au moins un analyte dans un fluide corporel. Le dispositif médical (111) comprend au moins un élément fonctionnel (117) implantable et au moins une commande (140) présentant au moins un composant électronique (130, 132, 134, 136). L'élément fonctionnel (117) peut être relié à la commande (140). La commande (140) comporte un boîtier (142) pourvu d'au moins une enveloppe métallique (144). La commande (140) comporte au moins un dispositif de communication sans fil (176). L'enveloppe métallique (144) comporte au moins une structure à fente (148). Le dispositif de communication (176) est conçu de manière à communiquer par l'intermédiaire de la structure à fente (148) avec au moins un appareil extérieur.
PCT/EP2011/059327 2010-06-08 2011-06-07 Capteur d'analyte pourvu d'une antenne à fente WO2011154372A1 (fr)

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EP11723090.4A EP2579769A1 (fr) 2010-06-08 2011-06-07 Capteur d'analyte pourvu d'une antenne à fente
CN2011800282591A CN102917636A (zh) 2010-06-08 2011-06-07 具有缝隙天线的分析物传感器

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EP10165193.3 2010-06-08

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EP3138488A1 (fr) 2015-09-02 2017-03-08 Roche Diabetes Care GmbH Module de détection et kit de détermination d'une concentration d'analyte
EP3138489A1 (fr) 2015-09-02 2017-03-08 Roche Diabetes Care GmbH Kit permettant de déterminer une concentration d'analyte

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US20170317530A1 (en) * 2016-04-29 2017-11-02 Qualcomm Incorporated Methods and system for wireless power transmission via a shielding antenna
WO2018140623A1 (fr) * 2017-01-26 2018-08-02 Cardiac Pacemakers, Inc. Dispositif sans fil présentant des composants surmoulés
CN107946737A (zh) * 2017-11-06 2018-04-20 徐州工程学院 一种具有射频识别功能的车牌及其制造方法
CN111588985B (zh) * 2020-05-27 2021-02-19 微智医疗器械有限公司 植入装置及其组装方法

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EP3138488A1 (fr) 2015-09-02 2017-03-08 Roche Diabetes Care GmbH Module de détection et kit de détermination d'une concentration d'analyte
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